RUSCH IPN050421Recalls & reported problems
Teleflex Incorporated · RUSCH Gold Pediatric Foley Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704303066), received between Feb 17, 2021 and Feb 17, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Deflate2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2021Failure to Deflate
COMPLAINT DESCRIPTION: WHEN PERFORMING THE BALLOON TEST ON THE 2-WAY FOLEY PROBE NO.16 WITH 10ML DISTILLED WATER, IT WAS FOUND THAT WHEN REMOVING THE WATER FROM THE BALLOON, IT DID NOT DEFLATE, MAKING IT IMPOSSIBLE TO USE THE PRODUCT AND DISCARDING IT AND OPENING A NEW PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11338077 ↗MalfunctionFeb 17, 2021Failure to Deflate
COMPLAINT DESCRIPTION: WHEN PERFORMING THE BALLOON TEST ON THE 2-WAY FOLEY PROBE NO.16 WITH 10ML DISTILLED WATER, IT WAS FOUND THAT WHEN REMOVING THE WATER FROM THE BALLOON, IT DID NOT DEFLATE, MAKING IT IMPOSSIBLE TO USE THE PRODUCT AND DISCARDING IT AND OPENING A NEW PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11338051 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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